Define-XML 2.1

Define-XML provides metadata documentation for CDISC datasets.

Overview

Define-XML is:

• Required for FDA electronic submissions
• Describes dataset structure and content
• Documents variable definitions
• Provides value-level metadata

What Define-XML Contains

Dataset Metadata

• Dataset names and descriptions
• Domain structure
• Keys and sort order
• Dataset locations

Variable Metadata

• Variable names and labels
• Data types and lengths
• Origin information
• Controlled terminology references

Value-Level Metadata

• Specific value definitions
• Conditional logic
• Derivation methods

Computational Methods

• Derivation algorithms
• Imputation rules
• Analysis methods

Define-XML 2.1 Structure

Root Element

<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3"
     xmlns:def="http://www.cdisc.org/ns/def/v2.1"
     ODMVersion="1.3.2"
     FileType="Snapshot"
     FileOID="DEFINE-XML-EXAMPLE">

Key Components

Creating Define-XML

Automatic Generation

Trial Submission Studio generates Define-XML from:

1. Mapped datasets
2. Variable definitions
3. Controlled terminology
4. Validation rules

Export Steps

1. Complete all domain mappings
2. Run validation
3. Click Export → Define-XML
4. Review generated metadata
5. Add comments/methods if needed
6. Click Save

Generated Content

The exported Define-XML includes:

Define-XML Elements

ItemGroupDef (Datasets)

<ItemGroupDef OID="IG.DM"
              Name="DM"
              Repeating="No"
              Domain="DM"
              def:Structure="One record per subject"
              def:Class="SPECIAL PURPOSE">
    <Description>
        <TranslatedText xml:lang="en">Demographics</TranslatedText>
    </Description>
    <ItemRef ItemOID="IT.DM.STUDYID" OrderNumber="1" Mandatory="Yes"/>
    <!-- More ItemRefs -->
</ItemGroupDef>

ItemDef (Variables)

<ItemDef OID="IT.DM.USUBJID"
         Name="USUBJID"
         DataType="text"
         Length="50"
         def:Origin="CRF">
    <Description>
        <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
    </Description>
</ItemDef>

CodeList (Controlled Terminology)

<CodeList OID="CL.SEX"
          Name="Sex"
          DataType="text">
    <CodeListItem CodedValue="M">
        <Decode>
            <TranslatedText xml:lang="en">Male</TranslatedText>
        </Decode>
    </CodeListItem>
    <CodeListItem CodedValue="F">
        <Decode>
            <TranslatedText xml:lang="en">Female</TranslatedText>
        </Decode>
    </CodeListItem>
</CodeList>

Variable Origins

Define-XML documents where data comes from:

Customizing Define-XML

Adding Comments

Add explanatory comments for:

• Complex derivations
• Data collection notes
• Exception documentation

Computational Methods

Document derivation algorithms:

• Formulas
• Conditions
• Source variables

Value-Level Metadata

For variables with parameter-dependent definitions:

• Different units by test
• Conditional codelists
• Test-specific origins

Validation

Schema Validation

Define-XML is validated against:

• CDISC Define-XML 2.1 schema
• Stylesheet rendering rules

Common Issues

FDA Requirements

Submission Package

• define.xml - Metadata file
• define.pdf - Rendered stylesheet (optional)
• Referenced XPT datasets

Naming Convention

• File: define.xml (lowercase)
• Location: Study root folder

Stylesheet

Include the CDISC stylesheet for rendering:

<?xml-stylesheet type="text/xsl" href="define2-1.xsl"?>

Best Practices

1. Generate early - Create Define-XML as you build datasets
2. Review carefully - Verify all metadata is accurate
3. Document derivations - Explain complex logic
4. Test rendering - View with stylesheet before submission
5. Validate - Use Define-XML validators

Next Steps

• XPT Format - Data file format
• Dataset-XML - Alternative data format
• Exporting Data - Export guide